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Regulatory Requirement Document Section
ISO 13485:2016 Sections 5.6.2 and 7.3.3 All


This SOP describes how the organization identifies changes to regulation applicable either to the organization as a manufacturer or its products in the market. This process shall ensure that changes are identified early enough and required changes are implemented in a timely manner so that regulatory compliance is guaranteed at all times.

Process Steps

1. Regulatory Input / Review

The QMO is responsible to gather all available regulatory information that is potentially relevant for the organization and its medical device(s) based on respective documentation provided by the Product Manager(s). Input may entail statutory laws, regulations and guidance documents. The QMO analyzes the applicability of relevant regulations and documents his assessment in a List of Applicable Regulations.

Every relevant regulation is reviewed at least once per year, every time before a new medical device is placed on the market or as specified by the List of Applicable Regulations.

Participants QMO
Input Medical device specification (technical documentation), Available regulatory requirements
Output List of regulatory requirements

2. Actions Based on Applicable Regulation

If a new or revised applicable regulation is brought to his/her attention, the QMO updates the List of Applicable Regulations. Additionally, the technical documentation and other QMS documents (e.g. the quality manual) is checked and updated if necessary.

The QMO communicates new or revised regulation to relevant members of the organization (e.g. process owners or product managers). Management is informed of new or revised regulation at least annually (for class II or higher: as part of the Management Review).

Participants QMO
Input New or revised regulation
Output List of regulatory requirements (updated), Communication to relevant members of the organization

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